NAPROXEN SODIUM CAPSULE, LIQUID FILLED [SHOPKO STORES OPERATING CO., LLC.]

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NAPROXEN SODIUM CAPSULE, LIQUID FILLED [SHOPKO STORES OPERATING CO., LLC.]
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NDC 37012-748-40
Set ID f42c7006-3168-4bbb-b35c-cb9f29bf4505
Category HUMAN OTC DRUG LABEL
Packager Shopko Stores Operating Co., LLC.
Generic Name
Product Class
Product Number
Application Number ANDA208363
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  • Active ingredient (in each capsule)

    Naproxen sodium 220 mg

    (naproxen 200 mg) (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • minor pain of arthritis
      • muscular aches
      • backache
      • menstrual cramps
      • headache
      • toothache
      • the common cold
    • temporarily reduces fever 
  • Warnings

    Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    • skin reddening
    • rash
    • blisters

    If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • have 3 or more alcoholic drinks every day while using this product
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • take more or for a longer time than directed

    Heart attack and stroke: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery

    Ask a doctor before use if

    • the stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease,asthma, or had a stroke 
    • you are taking a diuretic
    • you have problems or serious side effects from taking pain relievers or fever reducers

    Ask a doctor or pharmacist before use if you are

    • under a doctor’s care for any serious condition
    • taking any other drug

    When using this product

    take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • have bloody or black stools
      • vomit blood
      • have stomach pain that does not get better
    • you have symptoms of heart problems or stroke:
      • chest pain
      • slurred speech
      • leg swelling
      • trouble breathing
      • weakness in one part or side of body
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • you have difficulty swallowing
    • it feels like the capsule is stuck in your throat

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222).

  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • drink a full glass of water with each dose
    • if taken with food, this product may take longer to work
    • adults and children 12 years and older:
      • take 1 capsule every 8 to 12 hours while symptoms last
      • for the first dose you may take 2 capsules within the first hour
      • do not exceed 2 capsules in any 8- to 12-hour period
      • do not exceed 3 capsules in a 24-hour period
    • children under 12 years: ask a doctor
  • Other information

    • each capsule contains: sodium 20 mg
    • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
    • read all directions and warnings before use. Keep carton.
    • swallow whole; do not crush, chew, or dissolve
  • Inactive ingredients

    FD&C blue #1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitan, sorbitol solution, titanium dioxide, white ink

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    †Compare to Aleve® active ingredient

    NAPROXEN SODIUM

    CAPSULES 220 mg

    Pain Reliever; Fever reducer (NSAID)

    Strength To Last 12 Hours

    LIQUID GEL**

    (**LIQUID_FILLED CAPSULES)

    †This product is not manufactured or distributed by Bayer HealthCare, LLC distributor of Aleve®.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Packaged by: PL Developments

    200 Hicks Street

    Westbury, NY 11590, USA

    ©2018 Shopko Stores

    Operating Co., LLC

    www.shopko.com

  • Product Label

    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

    SHOPKO CARE Naproxen Sodium 220 mg Softgels

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-748
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    ALCOHOL (UNII: 3K9958V90M)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code PC19
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-748-401 in 1 BOX12/31/201812/30/2022
    140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20836312/31/201812/30/2022
    Labeler - Shopko Stores Operating Co., LLC. (023252638)
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